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OpenTrials
Completed

NCT Number: NCT03933644

Ambu Aura GainTM Guided vs Non Guided in Edentulous Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

The Ambu® Aura GainTM is a relatively new 2nd generation Supraglottic Airway Device (SGA) with a second port, providing gastric access to drain gastric content and air and it has an intergrated bite-block that helps avoiding rotation of the SGA.

It has been described and it is known from daily routine, that SGA in edentulous patient provide inferior oropharyngeal leak pressure (OLP).

The aim of the study is to evaluate if the placement of a gastric tube through the second orifice leads to better OLP and lowers the number of intervention needed for replacing the SGA.

The study also evaluates the OLP after 15 minutes and after 30 minutes.

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Key information

Conditions

Oropharyngeal Leak Pressure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUInnsbruck

Innsbruck, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I - 3
  • Signed informed consent
  • Age 18 - 90 years
  • Edentolous (or partial) patients
  • Patients scheduled for elective surgery

Exclusion criteria

  • Patients with a known or predicted difficult airway
  • Patients with anatomical disorders in the upper airway, the oesophagus or the trachea
  • Patients at risk for aspiration
  • Body mass index (BMI) > 40 kg/m2

Treatment and study plan

Gastric Tube

Device

SGA is inserted with a gastric tube as guide for insertion

No gastric Tube

Device

SGA is inserted without a gastric tube as guide for insertion

Primary outcomes

  1. Oropharyngeal Leak Pressure

    Time frame: immediately after insertion

    after insertion

Secondary outcomes

  1. Oropharyngeal Leak Pressure

    Time frame: 15 minutes

    after 15 minutes

  2. Oropharyngeal Leak Pressure

    Time frame: 30 minutes

    after 30 minutes

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

Comparison of the Ambu Aura GainTM With Gastric Tube Versus the Ambu Aura GainTM Without Gastric Tube in Endontolous Patient

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 1, 2019
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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